Neonatal SeizuresLEV-NEONCT07401433
Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hospital.
A study testing Levetiracetam and Phenobarbital Sodium Injection in people with Neonatal Seizures, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial summary
Neonatal seizures are a common neurological emergency in newborn babies and can lead to serious brain injury if not treated promptly. Phenobarbitone is commonly used as first-line treatment, but it is associated with delayed seizure control and adverse effects such as sedation and poor feeding. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Seizures
- What is being tested?
- Levetiracetam and Phenobarbital Sodium Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Apr 2024to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates (0-28 days old) with clinically diagnosed seizures.
- Both term and preterm neonates.
- Admitted to the neonatal intensive care unit (NICU) or pediatric ward.
- Written informed consent obtained from parents or legal guardians.
Who cannot join
- Neonates with major congenital anomalies or genetic syndromes.
- Neonates with severe renal or hepatic impairment.
- Neonates with metabolic disorders requiring specific treatment (e.g., hypoglycemia, hypocalcemia) unless seizures persist after correction.
- Neonates already receiving anticonvulsant therapy prior to admission.
- Neonates with confirmed meningitis or central nervous system infections requiring specific management (unless seizures persist after appropriate treatment).
- Neonates with life-threatening conditions where study treatment cannot be safely administered.
- Parents or legal guardians refusing consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Levetiracetam in the Treatment of Neonatal Seizures Presenting at Tertiary Care Hospital.
Neonatal seizures are a common neurological emergency in newborn babies and can lead to serious brain injury if not treated promptly. Phenobarbitone is commonly used as first-line treatment, but it is associated with delayed seizure control and adverse effects such as sedation and poor feeding.
This study was conducted to compare the effectiveness and safety of levetiracetam with conventional antiepileptic drugs (phenobarbitone with or without phenytoin) in the treatment of neonatal seizures.
Read more
In this randomized controlled trial, newborns aged 0 to 28 days diagnosed with seizures were randomly assigned to receive either intravenous levetiracetam or phenobarbitone-based therapy. The main outcomes assessed were seizure control within 40 minutes, seizure freedom at 24 and 48 hours, recurrence of seizures, time taken to control seizures, adverse effects, and mortality.
The results of this study aim to provide evidence on whether levetiracetam is a safer and more effective alternative for managing neonatal seizures in a tertiary care hospital setting.
Read the detailed description
This study is a prospective, double-blinded, randomized controlled parallel-group trial conducted in the Neonatal Intensive Care Unit of the Department of Pediatrics, MTI District Head Quarter Hospital, Dera Ismail Khan. The study was carried out over a period of one year after approval from the Institutional Research and Ethics Board.
A total of 260 neonates aged 0 to 28 days with clinically diagnosed neonatal seizures were enrolled after obtaining written informed consent from parents or legal guardians. Neonates who were already receiving antiepileptic drugs or had congenital cardiac or renal diseases were excluded. Participants were randomly allocated into two equal groups using a table of random numbers with allocation concealment through sequentially numbered sealed opaque envelopes.
Group A received intravenous levetiracetam administered at a rate of 1 mg/kg/min, followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Group B received phenobarbitone as first-line therapy with a loading dose of 20 mg/kg followed by maintenance dosing. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. No crossover between groups occurred.
The primary outcome was seizure cessation within 40 minutes of drug administration. Secondary outcomes included seizure freedom at 24 and 48 hours, recurrence of seizures, mean time to seizure control, adverse effects such as sedation, respiratory suppression, hypotension, and mortality. All patients were monitored in the neonatal intensive care unit for five days and followed for up to 14 weeks after discharge.
Data were analyzed using SPSS software. Outcomes were compared between groups to evaluate the efficacy and safety of levetiracetam compared with phenobarbitone-based therapy in the management of neonatal seizures.
- Conditions
- Neonatal Seizures
- Being tested
- Levetiracetam, Phenobarbital Sodium Injection
- Keywords
- Neonatal seizures, Levetiracetam, Phenobarbitone, Antiepileptic drugs, Neonatal intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Neonates with clinically diagnosed seizures received intravenous levetiracetam as the first-line anticonvulsant. Levetiracetam was administered at a rate of 1 mg/kg/min followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Seizure response and adverse effects were monitored.
Phenobarbital Sodium InjectionDrug
Phenobarbitone will be administered intravenously as the first-line anticonvulsant for neonatal seizures. Initial loading dose 20 mg/kg IV. If seizures persist after 20 minutes, a second dose of 10 mg/kg IV will be given. Maintenance dose of 5 mg/kg IV/PO once daily will be continued until seizure control is achieved or until discharge. Seizure response and adverse effects will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Levitiracetam Group | Experimental | Neonates presenting with clinically diagnosed seizures will receive intravenous levetiracetam as the first-line anticonvulsant. Initial dose 20 mg/kg IV, followed by 20 mg/kg IV after 12 hours if seizures persist. Maintenance dose will be 10 mg/kg IV/PO twice daily as per hospital protocol. Seizure control and side effects will be monitored. Receives: Drug: Levetiracetam |
| Phenobarbitone Group | Active comparator | Neonates with clinically diagnosed seizures received intravenous phenobarbitone as the first-line anticonvulsant with a loading dose of 20 mg/kg followed by maintenance dosing of 3-5 mg/kg/day. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. Seizure response and adverse effects were monitored. Receives: Drug: Phenobarbital Sodium Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Cessation Within 40 Minutes
Proportion of neonates with clinically diagnosed seizures whose seizures stopped completely within 40 minutes after administration of the first-line anticonvulsant.
Measured: Immediately after first-line drug administration (within 40 minutes)
Secondary outcomes (5)
Time to Seizure Cessation
Time duration from administration of the first dose to complete cessation of seizures.
Measured: From first-line drug administration to seizure cessation (up to 40 minutes)
Need for Second-Line Anticonvulsant
Proportion of neonates requiring second-line anticonvulsant therapy due to failure of initial treatment.
Measured: Immediately after first-line treatment failure (within 40 minutes of initial drug administration)
Seizure Recurrence During Hospital Stay
Number of neonates who develop recurrent seizures after initial control during the hospital stay.
Measured: From initial seizure control through 7 days of hospitalization
Incidence of Adverse Drug Reactions
Incidence of adverse effects (e.g., sedation, hypotension, respiratory depression, rash, feeding intolerance) associated with levetiracetam or phenobarbitone.
Measured: From first drug administration through the first 5 days of hospitalization
Mortality
Number of deaths occurring during hospital stay among neonates treated with levetiracetam or phenobarbitone.
Measured: From enrollment through assessment at discharge, 28 days and 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start8 Apr 2024
- Primary completion31 Mar 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neonatal SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel treatment groups: intravenous levetiracetam or phenobarbitone-based therapy, with no crossover between groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Collaborators
- Gomal Medical College
- Responsible party
- Principal investigator, Gohar Ali, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401433
- Sponsor's protocol ID
- DHQ-DIK-IREB NO. 4806
- Acronym
- LEV-NEO
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study is conducted at a single tertiary care hospital with limited resources, and the dataset contains sensitive clinical information of neonates. Data confidentiality and privacy of participants will be maintained in accordance with institutional ethical guidelines. Only aggregate data and study results will be published. De-identified data may be shared upon reasonable request and approval from the institutional ethics committee.
Publications
Isguder R, Guzel O, Agin H, Yilmaz U, Akarcan SE, Celik T, Unalp A. Efficacy and safety of IV levetiracetam in children with acute repetitive seizures. Pediatr Neurol. 2014 Nov;51(5):688-95. doi: 10.1016/j.pediatrneurol.2014.07.021. Epub 2014 Jul 22.
PubMed 25172096Khan O, Cipriani C, Wright C, Crisp E, Kirmani B. Role of intravenous levetiracetam for acute seizure management in preterm neonates. Pediatr Neurol. 2013 Nov;49(5):340-3. doi: 10.1016/j.pediatrneurol.2013.05.008. Epub 2013 Aug 3.
PubMed 23921284Sourbron J, Chan H, Wammes-van der Heijden EA, Klarenbeek P, Wijnen BFM, de Haan GJ, van der Kuy H, Evers S, Majoie M. Review on the relevance of therapeutic drug monitoring of levetiracetam. Seizure. 2018 Nov;62:131-135. doi: 10.1016/j.seizure.2018.09.004. Epub 2018 Sep 12.
PubMed 30237016Efficacy of levetiracetam as the first line antiepileptic drug in neonatal seizures (ResearchGate PDF).
Sharpe C, Reiner GE, Davis SL, Nespeca M, Gold JJ, Rasmussen M, Kuperman R, Harbert MJ, Michelson D, Joe P, Wang S, Rismanchi N, Le NM, Mower A, Kim J, Battin MR, Lane B, Honold J, Knodel E, Arnell K, Bridge R, Lee L, Ernstrom K, Raman R, Haas RH; NEOLEV2 INVESTIGATORS. Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial. Pediatrics. 2020 Jun;145(6):e20193182. doi: 10.1542/peds.2019-3182. Epub 2020 May 8.
PubMed 32385134McHugh DC, Lancaster S, Manganas LN. A Systematic Review of the Efficacy of Levetiracetam in Neonatal Seizures. Neuropediatrics. 2018 Feb;49(1):12-17. doi: 10.1055/s-0037-1608653. Epub 2017 Nov 27.
PubMed 29179233Weldegerima K, Gebremariam DS, Haftu H, Berhe G, Hadgu A, Mohammedamin MM. Neonatal Seizure Pattern, Outcome, and its Predictors Among Neonates Admitted to NICU of Ayder Comprehensive Specialized Hospital, Mekelle, Tigray, Ethiopia. Int J Gen Med. 2023 Sep 25;16:4343-4355. doi: 10.2147/IJGM.S414420. eCollection 2023.
PubMed 37781273Kaminiow K, Kozak S, Paprocka J. Neonatal Seizures Revisited. Children (Basel). 2021 Feb 18;8(2):155. doi: 10.3390/children8020155.
PubMed 33670692Ramantani G, Schmitt B, Plecko B, Pressler RM, Wohlrab G, Klebermass-Schrehof K, Hagmann C, Pisani F, Boylan GB. Neonatal Seizures-Are We there Yet? Neuropediatrics. 2019 Oct;50(5):280-293. doi: 10.1055/s-0039-1693149. Epub 2019 Jul 24.
PubMed 31340400
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Levetiracetam in the Treatment of Neonatal Seizures Presenting at Tertiary Care Hospital.
- ClinicalTrials.gov ID
- NCT07401433
- Acronym / sponsor ID
- LEV-NEO / DHQ-DIK-IREB NO. 4806
- Conditions
- Neonatal Seizures
- Keywords
- Neonatal seizures, Levetiracetam, Phenobarbitone, Antiepileptic drugs, Neonatal intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Collaborators
- Gomal Medical College
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neonatal seizures are a common neurological emergency in newborn babies and can lead to serious brain injury if not treated promptly. Phenobarbitone is commonly used as first-line treatment, but it is associated with delayed seizure control and adverse effects such as sedation and poor feeding.
This study was conducted to compare the effectiveness and safety of levetiracetam with conventional antiepileptic drugs (phenobarbitone with or without phenytoin) in the treatment of neonatal seizures.
In this randomized controlled trial, newborns aged 0 to 28 days diagnosed with seizures were randomly assigned to receive either intravenous levetiracetam or phenobarbitone-based therapy. The main outcomes assessed were seizure control within 40 minutes, seizure freedom at 24 and 48 hours, recurrence of seizures, time taken to control seizures, adverse effects, and mortality.
The results of this study aim to provide evidence on whether levetiracetam is a safer and more effective alternative for managing neonatal seizures in a tertiary care hospital setting.
Detailed description
This study is a prospective, double-blinded, randomized controlled parallel-group trial conducted in the Neonatal Intensive Care Unit of the Department of Pediatrics, MTI District Head Quarter Hospital, Dera Ismail Khan. The study was carried out over a period of one year after approval from the Institutional Research and Ethics Board.
A total of 260 neonates aged 0 to 28 days with clinically diagnosed neonatal seizures were enrolled after obtaining written informed consent from parents or legal guardians. Neonates who were already receiving antiepileptic drugs or had congenital cardiac or renal diseases were excluded. Participants were randomly allocated into two equal groups using a table of random numbers with allocation concealment through sequentially numbered sealed opaque envelopes.
Group A received intravenous levetiracetam administered at a rate of 1 mg/kg/min, followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Group B received phenobarbitone as first-line therapy with a loading dose of 20 mg/kg followed by maintenance dosing. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. No crossover between groups occurred.
The primary outcome was seizure cessation within 40 minutes of drug administration. Secondary outcomes included seizure freedom at 24 and 48 hours, recurrence of seizures, mean time to seizure control, adverse effects such as sedation, respiratory suppression, hypotension, and mortality. All patients were monitored in the neonatal intensive care unit for five days and followed for up to 14 weeks after discharge.
Data were analyzed using SPSS software. Outcomes were compared between groups to evaluate the efficacy and safety of levetiracetam compared with phenobarbitone-based therapy in the management of neonatal seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel treatment groups: intravenous levetiracetam or phenobarbitone-based therapy, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Levitiracetam Group | Experimental | Drug: LevetiracetamNeonates presenting with clinically diagnosed seizures will receive intravenous levetiracetam as the first-line anticonvulsant. Initial dose 20 mg/kg IV, followed by 20 mg/kg IV after 12 hours if seizures persist. Maintenance dose will be 10 mg/kg IV/PO twice daily as per hospital protocol. Seizure control and side effects will be monitored. |
| Phenobarbitone Group | Active comparator | Drug: Phenobarbital Sodium InjectionNeonates with clinically diagnosed seizures received intravenous phenobarbitone as the first-line anticonvulsant with a loading dose of 20 mg/kg followed by maintenance dosing of 3-5 mg/kg/day. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. Seizure response and adverse effects were monitored. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Neonates (0-28 days old) with clinically diagnosed seizures.
- Both term and preterm neonates.
- Admitted to the neonatal intensive care unit (NICU) or pediatric ward.
- Written informed consent obtained from parents or legal guardians.
Key exclusion criteria (7 listed)
- Neonates with major congenital anomalies or genetic syndromes.
- Neonates with severe renal or hepatic impairment.
- Neonates with metabolic disorders requiring specific treatment (e.g., hypoglycemia, hypocalcemia) unless seizures persist after correction.
- Neonates already receiving anticonvulsant therapy prior to admission.
- Neonates with confirmed meningitis or central nervous system infections requiring specific management (unless seizures persist after appropriate treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamNeonates with clinically diagnosed seizures received intravenous levetiracetam as the first-line anticonvulsant. Levetiracetam was administered at a rate of 1 mg/kg/min followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Seizure response and adverse effects were monitored. | Drug | Levitiracetam Group |
| Phenobarbital Sodium InjectionPhenobarbitone will be administered intravenously as the first-line anticonvulsant for neonatal seizures. Initial loading dose 20 mg/kg IV. If seizures persist after 20 minutes, a second dose of 10 mg/kg IV will be given. Maintenance dose of 5 mg/kg IV/PO once daily will be continued until seizure control is achieved or until discharge. Seizure response and adverse effects will be monitored. | Drug | Phenobarbitone Group |
Primary outcome
Seizure Cessation Within 40 Minutes
Time frame: Immediately after first-line drug administration (within 40 minutes)
Proportion of neonates with clinically diagnosed seizures whose seizures stopped completely within 40 minutes after administration of the first-line anticonvulsant.
5 secondary outcomes
Time to Seizure Cessation
Time frame: From first-line drug administration to seizure cessation (up to 40 minutes)
Need for Second-Line Anticonvulsant
Time frame: Immediately after first-line treatment failure (within 40 minutes of initial drug administration)
Seizure Recurrence During Hospital Stay
Time frame: From initial seizure control through 7 days of hospitalization
Incidence of Adverse Drug Reactions
Time frame: From first drug administration through the first 5 days of hospitalization
Mortality
Time frame: From enrollment through assessment at discharge, 28 days and 90days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 25172096Isguder R, Guzel O, Agin H, Yilmaz U, Akarcan SE, Celik T, Unalp A. Efficacy and safety of IV levetiracetam in children with acute repetitive seizures. Pediatr Neurol. 2014 Nov;51(5):688-95. doi: 10.1016/j.pediatrneurol.2014.07.021. Epub 2014 Jul 22.
- Results publication: PubMed 23921284Khan O, Cipriani C, Wright C, Crisp E, Kirmani B. Role of intravenous levetiracetam for acute seizure management in preterm neonates. Pediatr Neurol. 2013 Nov;49(5):340-3. doi: 10.1016/j.pediatrneurol.2013.05.008. Epub 2013 Aug 3.
- Results publication: PubMed 30237016Sourbron J, Chan H, Wammes-van der Heijden EA, Klarenbeek P, Wijnen BFM, de Haan GJ, van der Kuy H, Evers S, Majoie M. Review on the relevance of therapeutic drug monitoring of levetiracetam. Seizure. 2018 Nov;62:131-135. doi: 10.1016/j.seizure.2018.09.004. Epub 2018 Sep 12.
- Results publicationEfficacy of levetiracetam as the first line antiepileptic drug in neonatal seizures (ResearchGate PDF).
- Results publication: PubMed 32385134Sharpe C, Reiner GE, Davis SL, Nespeca M, Gold JJ, Rasmussen M, Kuperman R, Harbert MJ, Michelson D, Joe P, Wang S, Rismanchi N, Le NM, Mower A, Kim J, Battin MR, Lane B, Honold J, Knodel E, Arnell K, Bridge R, Lee L, Ernstrom K, Raman R, Haas RH; NEOLEV2 INVESTIGATORS. Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial. Pediatrics. 2020 Jun;145(6):e20193182. doi: 10.1542/peds.2019-3182. Epub 2020 May 8.
- Results publication: PubMed 29179233McHugh DC, Lancaster S, Manganas LN. A Systematic Review of the Efficacy of Levetiracetam in Neonatal Seizures. Neuropediatrics. 2018 Feb;49(1):12-17. doi: 10.1055/s-0037-1608653. Epub 2017 Nov 27.
- Results publication: PubMed 37781273Weldegerima K, Gebremariam DS, Haftu H, Berhe G, Hadgu A, Mohammedamin MM. Neonatal Seizure Pattern, Outcome, and its Predictors Among Neonates Admitted to NICU of Ayder Comprehensive Specialized Hospital, Mekelle, Tigray, Ethiopia. Int J Gen Med. 2023 Sep 25;16:4343-4355. doi: 10.2147/IJGM.S414420. eCollection 2023.
- Results publication: PubMed 33670692Kaminiow K, Kozak S, Paprocka J. Neonatal Seizures Revisited. Children (Basel). 2021 Feb 18;8(2):155. doi: 10.3390/children8020155.
- Results publication: PubMed 31340400Ramantani G, Schmitt B, Plecko B, Pressler RM, Wohlrab G, Klebermass-Schrehof K, Hagmann C, Pisani F, Boylan GB. Neonatal Seizures-Are We there Yet? Neuropediatrics. 2019 Oct;50(5):280-293. doi: 10.1055/s-0039-1693149. Epub 2019 Jul 24.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study is conducted at a single tertiary care hospital with limited resources, and the dataset contains sensitive clinical information of neonates. Data confidentiality and privacy of participants will be maintained in accordance with institutional ethical guidelines. Only aggregate data and study results will be published. De-identified data may be shared upon reasonable request and approval from the institutional ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam and Phenobarbital Sodium Injection in people with Neonatal Seizures, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Cessation Within 40 Minutes (time frame: Immediately after first-line drug administration (within 40 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401433, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.